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The Revitive IX is indicated for:

• Relaxation of muscle spasms; .
• Prevention or retardation of disuse atrophy; ●
• Increasing local blood circulation; .
• Muscle re-education; .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
• Maintaining or increasing range of motion. .

The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:

The provided 510(k) summary for the Actegy's Revitive IX does not contain specific acceptance criteria or a dedicated study explicitly designed to prove the device meets pre-defined performance acceptance criteria in the way typically found for novel diagnostic algorithms or complex medical devices requiring clinical efficacy studies.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended uses, and safety standards. The performance data mentioned refer to general safety and functional testing, not to specific clinical performance metrics with pre-defined acceptance thresholds.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what information is available and indicate where information is absent.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily centered around safety, electromagnetic compatibility, biocompatibility, and functional equivalence to the predicate device. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy, etc.) provided in relation to the stated indications for use.

Study Details (Based on the provided text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable/Not specified. This was not a study involving a "test set" of patients or data in the context of diagnostic or clinical performance. The "performance data" refers to engineering and safety verification.
   • Data Provenance: Not applicable/Not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There was no "ground truth" to establish for a test set in a clinical performance context. The assessment was against engineering specifications and regulatory standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No test set for clinical performance was evaluated this way.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable as this is a physical medical device for muscle stimulation, not an AI algorithm. Its performance is measured directly by its electrical output and safety, not as an algorithm's classification accuracy.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the clinical sense. The "ground truth" for the performance data mentioned would be the relevant engineering standards (e.g., EN60601-1-2 for EMC) and the device's design specifications for electrical output and safety characteristics.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

   • Not applicable.

Summary of the Study:

The "study" or "performance data" referred to in the 510(k) submission for the Revitive IX comprises standard engineering and regulatory compliance testing. This includes:

• Biocompatibility testing: To ensure the materials in contact with the patient are safe.
• Electromagnetic compatibility (EMC) testing (EN60601-1-2:2007): To ensure the device operates correctly in its electromagnetic environment and does not interfere with other devices.
• Electrical Safety testing (EMDD (93/42EEC), UL 60601-1, CSA C22.2 No.601-1-M90): This covers aspects like patient leakage current, enclosure leakage current, and insulation.
• Functional performance verification: Confirming that the device's electrical output parameters (frequency, pulse type, voltage range) and operational features (channels, modes, controls) align with its design specifications and are comparable to the predicate device.

The overarching goal of these tests was to demonstrate that the Revitive IX is as safe and effective as its predicate devices and that its minor technological differences do not raise new issues of safety or effectiveness, thus justifying a finding of substantial equivalence. There was no clinical trial or algorithm performance study described in the provided document.

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